Ninepoint Medical Inc. – FDA Inspection, Oct 24, 2016

Record Details

This FDA Inspection record concerns Ninepoint Medical Inc., with an inspection on October 24, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Ninepoint Medical Inc.
Inspection Date: October 24, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: John A. Sciacchitano (Company Rep)

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ID · 6d0a728a-fdbd-4417-9583-f9dbd6047dc3

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 988924
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(g)Design validation - production units
21 CFR 820.30(g)Design validation - user needs and intended uses

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FDA Inspection

Ninepoint Medical Inc.October 24, 2016